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A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2025

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At a glance

  • Drugs Golimumab (Primary) ; Guselkumab (Primary) ; Guselkumab (Primary)
  • Indications Ulcerative colitis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms VEGA
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 15 Jun 2024 Results (at baseline (n=195), WK4 (n=42 substudy), and WK38 (n=172)) to explore early molecular changes in colon tissue in a subset of patients at WK4 to define mechanistic contributions of each monotherapy and combination; these parameters were evaluated again at WK38 to assess potential carry-over of efficacy, presented at the 25th Annual Congress of the European League Against Rheumatism.
  • 15 Nov 2023 Results (n=150) investigating the Differential and Combinatorial Mechanism of Action of Golimumab and Guselkumab in Ulcerative Colitis Induction Therapy presented at the ACR Convergence 2023
  • 12 Sep 2023 Results assessing Pharmacokinetics & Immunogenicity of Combination Therapy of Guselkumab & Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis presented at the 2023 American College of Clinical Pharmacology Annual Meeting

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